Vapor Inhaler Inhalant
NDC Package 36800-294-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vapor Inhaler (levmetamfetamine) inhalants is the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine do not use more often than every 2 hours adults and children 12 years of age and over 2 inhalations in each nostril children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril children under 6 years of age ask a doctor children under 2 years of age do not use. This formulation utilizes a inhalant delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-294 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-294-07
Package Description
1 INHALER in 1 BLISTER PACK / 198 INHALANT in 1 INHALER
Product Code
36800-294
11-Digit Billing Format
36800029407

Clinical Specifications

Proprietary Name
Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health
Non-Proprietary Name
Levmetamfetamine
Substance Name
Levmetamfetamine
Dosage Form
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
LEVMETAMFETAMINE 50 mg/1
Usage Information
The product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine do not use more often than every 2 hours adults and children 12 years of age and over 2 inhalations in each nostril children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril children under 6 years of age ask a doctor children under 2 years of age do not use

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-19-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 36800-294-07 identifies a specific commercial package of 1 inhaler in 1 blister pack / 198 inhalant in 1 inhaler of Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health, a human over the counter drug labeled by Topco Associates Llc. This inhalant is formulated for nasal use and contains levmetamfetamine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Topco Associates Llc on February 19, 2021. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800029407. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
36800-294-07
11-Digit CMS (5-4-2)
36800-0294-07

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.